# K021660: K-Assay LP (a) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Jul 25, 2002 after 66 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Kamiya H-ASSAY do Lp(a) Assay is an in vifmdiagnostic reagent for the quantitative determination of human Lp(a) in human serum by immunoturbidimetric assay. The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations. The K-ASSA Y Cp(a) Calibrator Set is an in vitro diagnostic reagent for cafibration ofthe K-ASSAYg Lp(a) Assay.

Source page: https://510kreport.com/device/K021660
Methodology: https://510kreport.com/methodology